PreDiabetesNCT03504683
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
A study testing Early TRE and Mid-day TRE in people with PreDiabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Early TRE and Mid-day TRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30-70 years old
- Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c >= 5.1%
- Fasting insulin less than 100.0 mU/l and, if HbA1c <5.7%, must also have fasting insulin >= 8.0 mU/l
- BMI between 30-60 kg/m^2
- Wake up at a regular time between 5-8 am
Who cannot join
- Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
- On weight loss medication
- Change in the dosage of a chronic medication within the past 2 months
- Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
- Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
- Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
Show all 18Show fewer
- Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
- Pregnant or breastfeeding
- Diagnosed psychiatric conditions
- Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
- Major change in health or medical history in the past 3 months
- Currently perform overnight shift work
- Regularly eat within a <10.5-hour period each day
- Lost or gained more than 4% of weight in the past 2 months
- Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
- Will travel outside the Central time zone in the 2 weeks prior to testing
- Will travel more than 1 time zone away during this study
- Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between ~8 am-3 pm), (2) 'Mid-day TRE' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.
- Conditions
- PreDiabetes
- Being tested
- Early TRE, Mid-day TRE, Control Schedule
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early TREBehavioural
Also called eTRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Mid-day TREBehavioural
Also called mTRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
Control ScheduleBehavioural
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
| Study group | Role | What they receive |
|---|---|---|
| Early TRE | Experimental | Not described Receives: Behavioral: Early TRE |
| Mid-day TRE | Experimental | Not described Receives: Behavioral: Mid-day TRE |
| Control Schedule | Placebo comparator | Not described Receives: Behavioral: Control Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour glucose levels
Mean 24-hour glucose levels (mg/dl)
Measured: 8 weeks
Mean 24-hour insulin levels
Mean 24-hour insulin levels (mU/l)
Measured: 8 weeks
Mean 24-hour C-peptide levels
Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.
Measured: 8 weeks
Insulin sensitivity
Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model
Measured: 8 weeks
Beta-cell responsivity index (a measure of beta-cell function)
Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model
Measured: 8 weeks
Glucose AUCs
Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period
Measured: 8 weeks
Insulin AUC
Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period
Measured: 8 weeks
C-peptide AUC
C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period
Measured: 8 weeks
Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values
mg/dl
Measured: 8 weeks
Secondary outcomes (8)
Mean 24-hour systolic and diastolic blood pressure
mmHg
Measured: 8 weeks
Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure
mmHg
Measured: 8 weeks
Percentage of individuals with non-dipping blood pressure phenotypes
Measured: 8 weeks
Heart Rate
beats per minute
Measured: 8 weeks
Lipids
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Measured: 8 weeks
High Sensitivity C-Reactive Protein (hs-CRP)
mg/l
Measured: 8 weeks
Cortisol
μg/dl
Measured: 8 weeks
8-isoprostane
pg/ml
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start17 Aug 2020
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M Peterson, University of Alabama at Birmingham
- Investigators
- Courtney M. Peterson, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504683
- Sponsor's protocol ID
- IRB-300001180
- Other IDs
- R01DK118236
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2018
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT03504683
- Acronym / sponsor ID
- IRB-300001180
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between ~8 am-3 pm), (2) 'Mid-day TRE' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.
| Arm | Type | Receives |
|---|---|---|
| Early TRE | Experimental | Behavioral: Early TRE |
| Mid-day TRE | Experimental | Behavioral: Mid-day TRE |
| Control Schedule | Placebo comparator | Behavioral: Control Schedule |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 30-70 years old
- Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c >= 5.1%
- Fasting insulin less than 100.0 mU/l and, if HbA1c <5.7%, must also have fasting insulin >= 8.0 mU/l
- BMI between 30-60 kg/m^2
- Wake up at a regular time between 5-8 am
Key exclusion criteria (18 listed)
- Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
- On weight loss medication
- Change in the dosage of a chronic medication within the past 2 months
- Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
- Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early TREAlso: eTREEat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser) | Behavioural | Early TRE |
| Mid-day TREAlso: mTREEat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser) | Behavioural | Mid-day TRE |
| Control ScheduleEat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser) | Behavioural | Control Schedule |
Primary outcome
Mean 24-hour glucose levels
Time frame: 8 weeks
Mean 24-hour glucose levels (mg/dl)
Mean 24-hour insulin levels
Time frame: 8 weeks
Mean 24-hour insulin levels (mU/l)
Mean 24-hour C-peptide levels
Time frame: 8 weeks
Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.
Insulin sensitivity
Time frame: 8 weeks
Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model
Beta-cell responsivity index (a measure of beta-cell function)
Time frame: 8 weeks
Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model
Glucose AUCs
Time frame: 8 weeks
Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period
Insulin AUC
Time frame: 8 weeks
Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period
C-peptide AUC
Time frame: 8 weeks
C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period
Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values
Time frame: 8 weeks
mg/dl
8 secondary outcomes
Mean 24-hour systolic and diastolic blood pressure
Time frame: 8 weeks
Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure
Time frame: 8 weeks
Percentage of individuals with non-dipping blood pressure phenotypes
Time frame: 8 weeks
Heart Rate
Time frame: 8 weeks
Lipids
Time frame: 8 weeks
High Sensitivity C-Reactive Protein (hs-CRP)
Time frame: 8 weeks
Cortisol
Time frame: 8 weeks
8-isoprostane
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney M. Peterson, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early TRE and Mid-day TRE in people with PreDiabetes, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour glucose levels (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.